Diclofenac Sodium/Misoprostol diclofenac-sodium-misoprostol is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Micro Labs Limited. The primary component is Diclofenac Sodium; Misoprostol.
| Product ID | 42571-134_c91bba4c-accf-214a-e053-2a95a90a34b6 |
| NDC | 42571-134 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Diclofenac Sodium/Misoprostol diclofenac-sodium-misoprostol |
| Generic Name | Diclofenac Sodium/misoprostol |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2021-09-01 |
| Marketing Category | ANDA / |
| Application Number | ANDA204355 |
| Labeler Name | Micro Labs Limited |
| Substance Name | DICLOFENAC SODIUM; MISOPROSTOL |
| Active Ingredient Strength | 75 mg/1; ug/1 |
| Pharm Classes | Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |